Medela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a medical device connector compatibility issue. The source text indicates the issue could cause a delay in delivery of fluids or medication, but contains no reports of actual illness, injury, or harm; the hazard is precautionary and functional rather than involving high-risk contamination or structural defect.
Plain-English summary
Medela Inc is recalling the ENFit ExSet Strl 60 enteral extension set (Model/Catalog Number ENF060182LD / 101033086, Lot Number 0000747253). The product may contain incorrect connectors and will not attach or misconnect to ENFit connections, making it incompatible with intended use.
This incompatibility could lead to a slight delay in the delivery of enteral nutritional fluids or oral medication to patients. Approximately 82,900 units were distributed to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, and VA.
Consumers and healthcare providers who have this product should discontinue use and contact Medela Inc for guidance on replacement or proper disposal.
The recalled product
- Product
- Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿…
- Manufacturer
- Medela Inc
- Affected units
- 82,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Code: Item Number ENF060182LD / 101033086
- Lot Number 0000747253
- Date of Manufacturing 2026-01-16
- Expiration Date 2029-01-16
- Carton GTIN 20020451101358
- Unit GTIN 00020451101354
Distribution
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